Title 902 | Chapter 020 | Regulation 106REG


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CABINET FOR HEALTH AND FAMILY SERVICES
Office of Inspector General
Division of Health Care
(Amended After Comments)

902 KAR 20:106.Operation and services; ambulatory surgical center.

Section 1.

Definitions.

(1)

"Admission" means the time after completion of the registration process and at the first instance of rendering medical care to the patient on the day of the scheduled procedure as a part, or in anticipation, of a surgery.

(2)

"Ambulatory surgical center" means a public or private institution that is:

(a)

Hospital-based Hospital based or freestanding;

(b)

Operated under the supervision of an organized medical staff; and

(c)

Established, equipped, and operated primarily for the purpose of providing surgical services to patients not requiring hospitalization and treatment of patients by surgery, whose recovery under normal circumstances is not expected to will not require inpatient care.

(3)

"Cabinet" is defined by KRS 216B.015(6)(5).

(4)

"Center" means an ambulatory surgical center.

(5)

"Licensee" means a person or business entity that has been issued and holds a valid ambulatory surgical center license from the cabinetfor Health and Family Services.

Section 2.

Administration and Operation.

(1)

Licensee.

(a)

The licensee shall be legally responsible for operation of the center and for compliance with federal, state, and local laws and administrative regulations pertaining to operation of the center.

(b)

The licensee shall develop written policies for the administration and operation of the center.

(c)

Medical staff shall approve medical policies that include the following:. Policies shall include.

1.

Personnel practices and procedures that shall be readily. These shall be available to personnel;

2.

Job descriptions for each level of personnel, including the authority, responsibilities, and actual work to be performed in each classification;

3.

Written infection control measures governing. Written procedures shall govern the use of aseptic techniques and procedures in all areas of the center;

4.

Sterilization of supplies;

5.

Disposal of patient waste and other potentially infectious materials;

6.

Examination by a pathologist of tissues removed during surgery, including the identification of. Policies shall identify tissues that which require examination and tissues that are exempted by the medical staff team from examination which do not;

7.

Procedures for consultation Instances in which consultations with other physicians, dentists, or podiatrists based on a patient's medical needsshall be required;

8.

A list of surgical procedures which may be performed in the center;

9.

The center's privileging process, including the granting and withdrawal of medical staff surgical privileges, and privileges for the administration of anesthetics; and

10.

Arrangement for transportation of patients who require hospital care;

11.

A surgical smoke safety and control policy that shall be available to staff in all areas where surgical smoke is generated; and

12.

Policies that assure compliance with KRS 216B.165 the reporting and investigation of quality of care and safety problems in accordance with KRS 216B.165, including assurance that retaliatory action shall not be taken against a staff member who in good faith reports a patient care or safety problem.

(2)

Personnel and administration.

(a)

Administrator. The center shall have:

1.

An administrator responsible for the daily day to day operation of the center; and

2.

A similarly qualified staff person for delegation of responsibilities for delegating that responsibility in the administrator's absence.

(b)

Current employee records shall be maintained and shall include:

1.

A resume of the employee's training and experience;

2.

Evidence of current licensure or registration, if required; and

3.

Evaluation of the employee's performance, including a report of any adverse incident involving the employeeReports of accidents occurring while the employee is on duty.

(c)

Medical staff requirements. The center shall have an organized medical staff responsible for:

1.

The quality of medical care provided in the center; and

2.

Oversight of for the ethical and professional practices of its members; and

3.

Developing.

1.

The medical staff shall develop the center's medical care policies.

(d)2.

Surgical procedures shall be performed by professionally qualified physicians, dentists, or podiatrists who:

1.

Are legally authorized under their scope of practice to perform the procedures; them and

2.

Have been granted clinical privileges by the center's to perform the procedures by the center through its medical staff or governing body.

(e)(d)

Pharmaceutical, radiology, or laboratory services provided directly by the center or through an agreement with another entity shall be provided under the direction of a licensed pharmacist, a physician specializing as a radiologist, or a physician specializing as a pathologist, respectively, on a full-time, part-time, or regular consultative basis.

(f)(e)

The center shall employ registered nurses on a full-time basis for patient care in the operating and postanesthesia recovery rooms.

(g)(f)

The center shall employ other nursing personnel, aides, and technicians as necessary required to meet the needs of the patients served by the center, including personnel to be responsible for supervision, indexing, and filing of medical records.

(3)

A center shall not retain a patient longer than twenty-four (24) hours from the time of admission to discharge.

(4)

The center shall not provide obstetric have provisions for obstetrical deliveries.

(5)

Physician coverage. A physician or a the practitioner that performs surgical procedures the surgery shall be present in the center until all patients have been discharged and have left the center.

(6)

The center shall have a physician on the medical staff with admitting privileges at in a nearby hospital who is responsible for admitting patients in need of inpatient care.

(7)

Medical records.

(a)

Content. The center shall maintain a complete, comprehensive, accurate, and legible medical record for each patient. The Adequate and complete medical records shall be prepared for all patients admitted to the surgical center. Notes shall be legibly written or typed and signed. A medical record shall include the following information:

1.

Name and address of the person the or agency responsible for the patient;

2.

Patient identification data, including the patient's:

a.

Name;

b.

Address;

c.

Age;

d.

Sex; and

e.

Marital status;

3.

Date of admission and discharge;

4.

Name of the referring and attending physician, dentist, or podiatristphysicians', dentists' and podiatrists' names;

5.

A medical history and physical evaluation that was performed and entered into the medical record no more than thirty (30) days prior to surgery;

6.

A surgical consent form that has been signed by the patient or the patient's his legal representative prior to the surgical procedure;

7.

All preoperative diagnostic studies and laboratory tests;

8.

Special examinations, such as consultations, clinical, laboratory, and x-ray;

9.

Nurses' notes;

10.

Complete medical record signed by the operating surgeon, including:

a.

Anesthesia record;

b.

Preoperative diagnosis:

c.

Operative procedures and findings;

d.

Postoperative diagnosis;

e.

Condition of patient upon discharge;

f.

Postoperative instructions; and

g.

If required, tissue diagnosis by a pathologist on specimens surgically removed;

11.

Charts including records of temperature, pulse, respiration, and blood pressure; and

12.

Medication record including:

a.

Name of medication;

b.

Dosage;

c.

Date and time of administration;

d.

Method of administration;

e.

Name of prescribing physician, dentist, or podiatrist; and

f.

Name of person who administered the medication; and

g.

Any allergies or abnormal drug reaction.

(b)

Indexing. The center shall have a system of identification and filing to assure Medical records shall be systematically filed for ready access to a patient's record by authorized personnel.

(c)

Ownership.

1.

Medical records shall be the property of the center.

2.

The original medical record shall not be removed from the center except by court order or subpoena.

3.

Copies of a medical record or portions of the record may be used and disclosed. Use and disclosure shall be as established by paragraph (d) of this subsection.

(d)

Confidentiality and Security: Use and Disclosure.

1.

The center shall maintain the confidentiality and security of medical records in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, as amended, including the security requirements mandated by subparts A and C of 45 C.F.R. Part 164, or as provided by applicable federal or state law.

2.

The center may use and disclose medical records. Use and disclosure shall be as established or required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164, or as established in this administrative regulation.

3.

A center may establish higher levels of confidentiality and security than required by HIPAA, 42 U.S.C. 1320d-2 to 1320d-8, and 45 C.F.R. Parts 160 and 164.

(e)

Records of patients shall not be removed from the center's custody except in accordance with a court order or subpoena. Medical records shall be made available if requested for inspection by a duly authorized representative representatives of the cabinet.

(f)(d)

The attending physician, dentist, or podiatrist shall complete and sign a patient's the medical record of the patient as soon as practicable after discharge, but not to exceed ten (10) days.

(g)(e)

 

1.

Orders for medication and treatment shall be dated, timed, and signed by the:

a.

Prescribing physician, dentist, or podiatrist;, or

b.

the Health care practitioner who receives the verbal order.

2.

A verbal order orders shall be followed by a written order and signed countersigned by the prescribing physician, dentist, or podiatrist within forty-eight (48) hours, except that a prescription for a records for Schedule II drug drugs shall be signed immediately.

3.

A record of medication administered to the patient shall be included in the record and signed by the health care professional person administering the medication.

(h)(f)

Retention of records. Medical records shall be retained for at least:

1.

Six (6) years from the date of discharge; or

2.

If a minimum of five (5) years or, in the case of a minor, three (3) years after the patient reaches the age of majority under state law, whichever is the longest.

(8)

Bedrails shall be available for patients in the admitting and recovery units.

Section 3.

Sanitary Environment. The surgical center shall provide a sanitary environment to avoid sources and transmission of infectioninfections.

(1)

An infection control committee composed of members of the medical and nursing staff shall be established and charged with responsibility for investigating, be responsible for controlling, and preventing infections in within the center.

(2)

Nondisposable sterile supplies shall be reprocessed if the integrity of the pack has not been maintained.

(3)

The center shall:

(a)

Have suitable equipment for rapid and routine sterilization of supplies, utensils, and equipment; and

(b)

Maintain a sterile storage area for the equipment to be kept shall store them in a clean, convenient, and orderly manner.

(4)

Continuing education shall be provided to all surgical center personnel on the cause, effect, transmission, prevention, and elimination of infections.

Section 4.

Surgical Services.

(1)

The center shall operate exclusively for the purpose of providing surgical services to patients not requiring hospitalization and in which the expected duration of services would not exceed twenty-four (24) hours following admissionprovide treatment of patients by surgery, whose recovery under normal circumstances will not require inpatient care.

(2)

The center shall have at least one (1) operating room.

(3)

A patient shall be examined:

(a)

By a physician, dentist, or podiatrist acting within the professional's scope of practice; and

(b)

Immediately prior to surgery to evaluate risks pertaining to:

1.

the risk of Anesthesia; and

2.

the risk of The procedure to be performed.

(4)

A registered nurse shall:

(a)

Be available to circulate at all times; and

(b)

Supervise each. The operating room rooms shall be supervised by a registered nurse.

(5)

The center shall have on file a list of all physicians, dentists, and podiatrists who have been granted with surgical privileges by the center's medical staff or governing body, including the scope of at the center and the privileges granted assigned to each practitionerby the medical staff.

(6)

The center shall maintain a complete and up-to-date operating room register.

(7)

The following equipment shall be available in the center:

(a)

Oxygen;

(b)

Mechanical ventilatory assistance equipment including airways, manual breathing bag, and ventilator;

(c)

Cardiac defibrillator;

(d)

Cardiac monitoring equipment;

(e)

Tracheostomy set;

(f)

Laryngoscopes and endotracheal tubes;

(g)

Suction equipment; and

(h)

Emergency medical equipment and supplies specified by the medical staff.

(8)

 

(a)

In accordance with KRS 216B.153, a center that utilizes an energy-generating device shall make use of a smoke evacuation system:

1.

That effectively captures and neutralizes surgical smoke at the site of origin and before the smoke can make ocular contact or contact with the respiratory tract of the occupants of the room; and

2.

During any surgical procedure that is likely to produce surgical smoke.

(b)

The cabinet shall impose fines in accordance with KRS 216B.990(8) for each violation of noncompliance with KRS 216B.153 only if the violation has not been remedied after the center has had an opportunity to correct the violation through the filing of a plan of correction in accordance with 902 KAR 20:008, Section 2(13).

(9)

The center shall have arrangements for obtaining an adequate supply of blood in a timely manner to meet the center's needs.

(10)(9)

A physician's, dentist's, or podiatrist's orders shall be in writing and signed by the physician, dentist, or podiatrist.

(11)(10)

Except for cases requiring only local infiltration anesthetics, a physician anesthesiologist, a physician qualified to administer anesthesia, a dentist qualified to administer anesthesia, or a certified registered nurse anesthetist acting under the direction of the operating surgeon shall administer the anesthetics and remain present during the surgical procedures and until the patient is fully recovered from the anesthetics.

(12)

 

(a)(11)

The physician, dentist, or podiatrist in charge of the patient shall be responsible for seeing that tissue removed during surgery is delivered to the center's pathologist.

(b)

The pathologist's and that an examination and report on any is made on the tissue removed during surgery shall be included in the patient's medical record unless the center's medical staff have adopted a written policy exempting certain types of removed tissue from examination, if required by the center's written policies.

(13)(12)

Voluntary interruption of pregnancies. An ambulatory surgical center shall comply with the applicable Kentucky statutes concerning the voluntary interruption of pregnancies, including KRS 311.710 to 311.810.

Section 5.

Postanesthesia Postanethesisa Recovery Services.

(1)

The center shall have at least one (1) postanesthesia recovery unit.

(2)

There shall be adequate staff available in the recovery unit so that no patient is left alone at any time.

(3)

A registered nurse shall be present in the recovery unit during the time that when a patient is recovering from anesthesia.

(4)

A registered nurse shall be available to the recovery unit at all times.

(5)

A registered nurse or health care professional person staffing the postanesthesia recovery unit shall be adequately trained in all aspects of postoperative and postanesthetic care.

(6)

The recovery unit nurse shall record a nursing note on each a patient to document, noting the following:

(a)

Postoperative abnormalities or complications;

(b)

Pulse;

(c)

Respiration;

(d)

Blood pressure;

(e)

Presence or absence of swallowing reflex;

(f)

Cyanosis; and

(g)

The general condition of the patient.

(7)

Available equipment shall include the following:

(a)

Suction machine;

(b)

Stethoscope;

(c)

Sphygmomanometer;

(d)

Emergency crash cart;

(e)

Necessary drugs; and

(f)

Oxygen.

(8)

 

(a)

The surgical center shall provide suitable accommodations for its patients.

(b)

There shall be adequate floor space, furnishings, bed linens, and other utensils, equipment and supplies reasonably required for the proper care of the patients accommodated.

Section 6.

Pharmaceutical Services.

(1)

The center shall have a licensed pharmacy or have arrangements for promptly obtaining prescribed drugs and biologicals from a pharmacy.

(2)

 

(a)

The center shall have provide appropriate methods and procedures for the storage, control, and administration of drugs and biologicals, developed with the advice of a licensed pharmacist.

(b)

The pharmacist shall properly label drugs for individual patients.

(3)

Licensed medical or nursing personnel shall administer medications in accordance with the established standards of practice set forth for:

(a)

Podiatrists licensed in accordance with KRS 311.400;

(b)

Physicians licensed in accordance with KRS 311.571;

(c)

Dentists licensed in accordance with KRS 313.030313.040 or 313.045;

(d)

Dental specialists defined by KRS 313.010(9)licensed in accordance with KRS 313.420; or

(e)

Nurses licensed in accordance with KRS 314.041, 314.042, or 314.051.

(4)

Controlled substances.

(a)

Controlled substances shall be kept under double lock (i.e., in a locked box in a locked cabinet). There shall be a controlled substances record that includes in which is recorded the:

1.

Name of the patient;

2.

Date and time;

3.

Kind of controlled substance;

4.

Dosage and method of administration of the controlled substance;

5.

Name of the physician or practitioner who prescribed the controlled substance; and

6.

Name of the nurse who administered the controlled substanceit.

(b)

In addition to the requirements established in paragraph (a) of this subsection, there shall be a recorded and signed:

1.

Schedule II controlled substances count daily conducted by a member of the nursing staff; and

2.

Schedule III, IV, and V controlled substances count once per week by a member of the nursing staff.

Section 7.

Radiology Services.

(1)

The center shall provide radiology services directly through an:

(a)

Agreement with a licensed hospital;, or

(b)

through an Independent radiology service.

(2)

The radiology service shall have a current license or registration pursuant to KRS 211.842 to 211.852.

(3)

If radiology services are provided directly by the center:

(a)

The radiology department shall be free of hazards for patients and personnel. Proper safety precautions shall be maintained against:;

1.

Fire and explosion hazards;

2.

Electrical hazards; and

3.

Radiation hazards;

(b)

A physician specializing in radiology shall supervise the department and interpret films that require specialized knowledge for accurate reading;

(c)

Signed reports shall be promptly entered into the medical record and duplicate copies kept in the department; and

(d)

Orders for radiology procedures shall be made by a physician, dentist, or podiatrist.

Section 8.

Laboratory Services.

(1)

The center shall provide laboratory services directly through:

(a)

Its own licensed laboratory;

(b)

, through An agreement with a laboratory in a licensed hospital;, or

(c)

through An agreement with a licensed laboratory nearby.

(2)

The medical laboratory providing services to the center shall be licensed pursuant to KRS 333.030, unless it is a part of a licensed hospital.

(3)

Laboratory examinations shall be made only upon the request of a physician, dentist, or podiatrist.

(4)

 

(a)

The laboratory shall provide tissue pathology and diagnostic cytology examinations.

(b)

Tissues removed from a patient during surgery shall be examined by a physician specializing in pathology if required by the center's written policies.

(5)

Laboratory and tissue pathology reports shall be signed and entered into the medical record.

Section 9.

Utilization Review.

(1)

The surgical center shall have in effect a plan for utilization review of the center's their services on at least a quarterly basis by a committee of physicians, dentists, or podiatrists who have no financial interest in the center.

(2)

Reviews shall be made of the center's admissions and professional services, furnished including utilization of surgical services and tissue reports.

ADAM MATHER, Inspector General
ERIC C. FRIEDLANDER, Secretary
APPROVED BY AGENCY: May 6, 2022
FILED WITH LRC: May 11, 2022 at 1:45 p.m.
CONTACT PERSON: Krista Quarles, Policy Analyst, Office of Legislative and Regulatory Affairs, 275 East Main Street 5 W-A, Frankfort, Kentucky 40621; phone 502-564-6746; fax 502-564-7091; email CHFSregs@ky.gov.

REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Kara Daniel; Stephanie Brammer-Barnes; Krista Quarles
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation establishes the minimum licensure requirements for the operation of and services provided by ambulatory surgical centers.
(b) The necessity of this administrative regulation:
This administrative regulation is necessary to comply with KRS 216B.042(1), which requires the Cabinet for Health and Family Services to establish licensure standards and procedures to ensure safe, adequate, and efficient health facilities and health services.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
This administrative regulation conforms to the content of KRS 216B.042(1) by establishing the minimum licensure requirements for the operation of and services provided by ambulatory surgical centers.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
This administrative regulation assists in the effective administration of the statutes by establishing the minimum licensure requirements for the operation of and services provided by ambulatory surgical centers.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
This amendment is required by KRS 216B.153, a new law created by the passage of SB 38 from the 2021 session of the Kentucky General Assembly. KRS 216B.153(2) directs the cabinet to promulgate administrative regulations to require a health facility that utilizes energy generating devices to use a smoke evacuation system during any surgical procedure that is likely to produce surgical smoke. In addition, this amendment makes technical changes to conform to the administrative regulation drafting requirements of KRS Chapter 13A to improve clarity and flow, and also makes general housekeeping changes. Additionally, in accordance with a request submitted during the public comment period, this amended after comments regulation modifies the wording of the cross-reference to KRS 216B.165 in Section (2)(1)(c)12..
(b) The necessity of the amendment to this administrative regulation:
This amendment is required by KRS 216B.153(2).
(c) How the amendment conforms to the content of the authorizing statutes:
This amendment conforms to the content of KRS 216B.153 by creating a requirement for ambulatory surgical centers to make use of a smoke evacuation system during any surgical procedure that is likely to produce surgical smoke.
(d) How the amendment will assist in the effective administration of the statutes:
This amendment will assist in the effective administration of the statutes by adding a requirement for surgical smoke evacuation systems pursuant to KRS 216B.153.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
This amendment affects ambulatory surgical centers that provide surgical procedures that are likely to produce surgical smoke. There are currently 49 ambulatory surgical centers licensed in Kentucky.
(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment:
Ambulatory surgical centers will be required to make use of a smoke evacuation system during any surgical procedure that is likely to produce surgical smoke.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
If an ambulatory surgical center does not currently have a smoke evacuation system, the facility will incur costs associated with the purchase of a system.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
Surgical smoke generated by the use of an energy-generating device during a surgical procedure contains toxic and biohazardous substances that present risks to perioperative team members and patients. Therefore, the use of smoke evacuation equipment required by this amendment will protect health care workers and patients from the harmful effects of surgical smoke.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
There are no additional costs to the Office of Inspector General for implementation of this amendment.
(b) On a continuing basis:
There are no additional costs to the Office of Inspector General for implementation of this amendment on a continuing basis.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
The source of funding used for the implementation and enforcement of the licensure function is from federal funds and state matching funds of general and agency appropriations.
(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
No increase in fees or funding is necessary to implement this amendment.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
This amendment does not establish or increase any fees.
(9) TIERING: Is tiering applied?
Tiering is not applicable as compliance with this administrative regulation applies equally to all ambulatory surgical centers regulated by it.

FISCAL NOTE
(1) What units, parts, or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation?
This administrative regulation affects Kentucky-licensed ambulatory surgical centers. This administrative regulation also impacts the Cabinet for Health and Family Services, Office of Inspector General.
(2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 216B.042, 216B.153
(3) Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.
(a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year?
Although KRS 216B.990(8) authorizes the cabinet to impose a fine ranging from $100 to $500 for each violation of KRS 216B.153, the cabinet is unable to predict with accuracy how many violations may be cited or otherwise determine the amount of fines that may be collected.
(b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years?
The cabinet is unable to predict with accuracy how many violations may be cited or otherwise determine the amount of fines that may be collected.
(c) How much will it cost to administer this program for the first year?
This amendment imposes no additional costs on the administrative body.
(d) How much will it cost to administer this program for subsequent years?
This amendment imposes no additional costs on the administrative body during subsequent years.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Revenues (+/-):
Expenditures (+/-):
Other Explanation:
(4) Estimate the effect of this administrative regulation on the expenditures and cost savings of regulated entities for the first full year the administrative regulation is to be in effect.
(a) How much cost savings will this administrative regulation generate for the regulated entities for the first year?
This amendment will not generate cost savings for regulated entities during the first year.
(b) How much cost savings will this administrative regulation generate for the regulated entities for subsequent years?
This amendment will not generate cost savings for regulated entities during subsequent years.
(c) How much will it cost the regulated entities for the first year?
Although KRS 216B.990(8) authorizes the cabinet to impose a fine ranging from $100 to $500 for each violation of KRS 216B.153, the cabinet is unable to predict with accuracy how many violations may be cited or otherwise determine the amount of fines that may be incurred by the regulated entities. In addition, if an ambulatory surgical center does not currently have a smoke evacuation system as defined by KRS 216B.153(1)(b), the facility will incur costs associated with the purchase of a system for procedures likely to produce surgical smoke.
(d) How much will it cost the regulated entities for subsequent years?
Same response as provided in (4)(c) above.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Cost Savings (+/-):
Expenditures (+/-):
Other Explanation:
(5) Explain whether this administrative regulation will have a major economic impact, as defined below.
"Major economic impact" means an overall negative or adverse economic impact from an administrative regulation of five hundred thousand dollars ($500,000) or more on state or local government or regulated entities, in aggregate, as determined by the promulgating administrative bodies. [KRS 13A.010(13)] This amendment will not have a major economic impact on ambulatory surgical centers.

FEDERAL MANDATE ANALYSIS COMPARISON
(1) Federal statute or regulation constituting the federal mandate.
45 C.F.R. 160, 164, 42 U.S.C. 1320d-2 - 1320d-8
(2) State compliance standards.
KRS 216B.042
(3) Minimum or uniform standards contained in the federal mandate.
45 C.F.R. 160, 164, and 42 U.S.C. 1320d-2 – 1320d-8 establish the HIPAA privacy rules to protect individuals’ medical records and other personal health information.
(4) Will this administrative regulation impose stricter requirements, or additional or different responsibilities or requirements, than those required by the federal mandate?
This administrative regulation does not impose requirements that are more strict than federal laws or regulations.
(5) Justification for the imposition of the stricter standard, or additional or different responsibilities or requirements.
Not applicable.

7-Year Expiration: 4/30/2026

Last Action: 5/20/2022


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